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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05055778
Other study ID # 3928
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date November 3, 2021
Est. completion date February 6, 2024

Study information

Verified date April 2024
Source University of Virginia
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the effectiveness of SmokefreeTXT, a smoking cessation text messaging program currently available to anyone in the United States through www.smokefree.gov, and to compare cessation outcomes for smokers living in different regions of Virginia while participants use the program. Participants will be asked to complete assessments at Baseline, 7 weeks, 3 months, and 6 months and will be asked to use a research version of SmokefreeTXT.


Recruitment information / eligibility

Status Completed
Enrollment 49
Est. completion date February 6, 2024
Est. primary completion date February 6, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Age 18 and over - Current cigarette smoker (has smoked at least 100 cigarettes in their lifetime and currently smokes) - Ability to read and speak English - Resident of Virginia - Owns a cell phone Exclusion Criteria: - Not a current smoker (e.g., started a quit attempt between providing interest information and starting the study) - Identity not able to be verified from information provided on interest form - Does not own a cell phone - Pregnant smoker or may become pregnant in the next 6 months - Lives in an area that has met recruitment criteria (after recruitment has begun)

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
SmokefreeTXT
The program is identical to the publicly available program available through the National Cancer Institute Smokefree.gov Initiative but has been set up to be delivered through a research account. The program will send 3-5 messages a day over 7 weeks, with one week to prepare for a quit attempt and 6 weeks of cessation support messages. Participants can get real time support for cravings, mood, and slips by texting "keywords" to the program. They keywords are CRAVE, MOOD, and SLIP. Participants can also re-set their quit date by texting NEW. The program asks questions each week to ask about smoking status and about mood and cravings.

Locations

Country Name City State
United States University of Virginia Charlottesville Virginia

Sponsors (1)

Lead Sponsor Collaborator
University of Virginia

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Self-reported smoking cessation 7-day point prevalence of abstinence (Question wording: Have you smoked a cigarette (even a puff) in the past 7 days? Response options: Yes; No) 7 weeks after study start
Primary Self-reported smoking cessation 7-day point prevalence of abstinence (Question wording: Have you smoked a cigarette (even a puff) in the past 7 days? Response options: Yes; No) 3 months
Secondary Self-reported continuous abstinence Continuous abstinence, 6 weeks after initiating the quit attempt (Question wording: In the last 6 weeks, have you smoked at all? Response options: Yes; No; Not sure) 7 weeks after study start
Secondary Self-reported continuous abstinence Continuous abstinence 3 months after initiating the quit attempt (Question wording: In the last 3 months, have you smoked at all? Response options: Yes; No; Not sure) 3 months
Secondary Self-reported smoking cessation 7-day point prevalence of abstinence (Question wording: Have you smoked a cigarette (even a puff) in the past 7 days? Response options: Yes; No) 6 months
Secondary Self-reported continuous abstinence Continuous abstinence 3 months after initiating the quit attempt (Question wording: In the last 6 months, have you smoked at all? Response options: Yes; No; Not sure) 6 months
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